New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:

09/29/2008

Trade Name:

Videx EC

Generic Name or Proper Name (*):

didanosine

Indications Studied:

HIV infection in >20 kg

Label Changes Summary:

* Extended indication from adults to children weighing e20kg who can swallow capsules * Dosing is based on body weight not to exceed adult dose * Adverse events (AEs) are generally similar to those seen in adults * Information on dose, AEs, population PK analysis, lab abnormalities, and historical clinical studies